Best Practices Guidelines for IV Preparation

Outline and Manual, by Colleen Huber, NMD, February 20, 2015

Contents

Compounding Conditions

The IV Preparation Room

The room in which compounded sterile products (CSPs) containing IV nutrients are prepared should rise to the following standards: to be adequately lit, with ventilation, air filters replaced once every two months, and cleaned on a regular basis, at least weekly, with all surfaces wiped from higher to lower. Paper towels or new cleaning cloths are used when wiping the counter tops used in IV preparation, as well as the containers that hold syringes or needles. It is essential to have a sink in this room for hand-washing.

Food and drink are not present or consumed in the IV Preparation Room. If non-sterile medicine is dispensed in the same room, such as herbal tinctures or homeopathic pillules, the medicines are carried out of the room before the patient consumes them. It is best if patients not enter the IV Preparation Room.

The counter top for IV preparation is of a non-porous surface. It is wiped down with a new clean wet cloth or paper towels and dried thoroughly at the end of every workday. Personnel working over the countertop do not sneeze, cough, sigh or even speak while working over the counter or any injectables. For speaking, one should back slightly away from the work area, or turn 90 degrees to speak to someone else, not facing forward over the injectables. In the event of a cough or a sneeze, one turns 180 degrees away, step away from the counter, and sneezes into one’s bent elbow, then changes the gloves or washes hands again, as below.

Needles and syringes used in IV preparation are kept in clean closed containers. They stay in their original manufactured packaging until the moment of use. Nothing enters those containers, at any time, whether solid, liquid or gas, that may compromise the sterility of the needles and syringes used in IV preparation.

Refrigerated injectables must be maintained at a temperature of 34 to 38 degrees Fahrenheit, until ready for use. The refrigerator is inside the IV preparation room. Again, no food or drink, or human specimens share the refrigerator with sterile injectables. Those injectables are kept in a dedicated refrigerator. The injectables are organized and clearly labelled, so that there is no more handling of them than necessary.

Vials of sterile liquids remain closed at all times and protected from room air. These vials should be stored in dedicated cabinets or drawers at room temperature, or in the dedicated refrigerator, as directed by the manufacturer, at all times except when needed for use.

Sterile versus non-sterile surfaces

When preparing fluids for intravenous preparation, solid and liquid objects that are sterile are kept apart at all times from solid and liquid objects that are not sterile. In effect, sterile touches only sterile; non-sterile touches only non-sterile. The only exception to this rule is that some sterile objects and substances at times touch small surfaces that are merely disinfected, such as the rubber stoppers of open vials. These are described below, always with an attempt to keep sterile surfaces isolated from non-sterile surfaces.

Solid items are considered sterile if: 1) they have been autoclaved in a dry cycle, or 2) if they have been placed in aluminum foil in a 320 degree F oven for two hours, or 3) in a pressure cooker of 15 psi for 15 minutes. (Information courtesy of University of Utah, http://teach.genetics.utah.edu/content/gsl/html/sterile_solid.html.) It should be noted that this is a higher standard for sterility than that specified in USP 797, referenced below.

Then all materials that are not part of that IV are disposed of; the sharps go in a designated sharps container, and the non-sharps can go in the regular waste. Empty glass vials may go to recycling.

Basic hygiene in preparation of compounded sterile products for IV administration

Only doctors at the clinic prepare CSPs for IV infusion for patients. Those doctors are in business dress or business casual dress or scrubs, if they choose. If the doctor has an upper respiratory infection, the doctor wears a mask that day. This is the case as well for all other personnel who handle intravenous fluids or who come into contact with patients.

Personal hygiene: hand washing and gloves

Prior to preparing an IV the doctor washes his or her hands thoroughly, covering every surface of the hands with water, then soap, then rubbing all surfaces of the hands, then rinsing and drying with a new paper towel. Alternatively, the doctor may choose to wear new disposable gloves, which do not need to be sterile. There is no need to both wash the hands and wear gloves, unless the doctor chooses to do so.

After washing hands, the doctor takes care not to touch patients, patient files, any part of his or her own clothing or body or face or hair, or other personnel, or other surfaces than the materials and workspace to be used in IV preparation.

Handling bottles and bags of sterile fluids

Bottles and bags of sterile fluids are examined to make sure that they are still as sealed and clean as when obtained from the manufacturer.

The sterile water container used to prepare the IV is placed next to or on a new paper towel.

Then the vials of sterile injectable nutrients are arranged in order on the paper towel.

Handling vials of sterile materials for preparation of IV treatments

Again, vials of sterile liquids remain closed at all times and protected from room air. Check the expiration date to be sure that every vial you access is not yet expired. Check to make sure that no particulate matter or stopper core has been introduced into the fluid in the vials. Check to make sure that the product is not frozen, not cloudy, not an unexpected color.

When a metal or plastic cap is peeled off of the vial of an injectable nutrient, be certain to never touch the exposed surface of the rubber stopper. Because that stopper will be pierced at least once, and possibly many times, that stopper must never come into contact with any non-sterile substance, except for a disinfecting alcohol pad or spray.

To disinfect, either spray the tops of each vial with isopropyl alcohol or wipe the rubber stopper of each vial with a new alcohol pad, as follows. Unwrap the alcohol pad, taking care not to contaminate the surface of the alcohol pad that is wiped onto the injectable vials. Disinfect the rubber stoppers on the vials with your new alcohol pad. Once that alcohol has dried, you can begin to prepare your IV for your patient. Please note that when we use alcohol pads, we are disinfecting but not sterilizing. This is an important distinction. While wiping the vial tops with the alcohol pads, we are creating a situation in which a disinfected surface (the top of the rubber stopper) comes into contact with a sterile surface (of the injectable fluid). This is the only exception to the rule of “Sterile only touches sterile; non-sterile only touches non-sterile.”

Handling needles and syringes

Peel back the manufacturer’s wrapper of the sterile 18 gauge no-core drawing needle, without touching the tip. Then peel back the manufacturer’s wrapper of the sterile syringe that you will use to draw the injectables, without touching the syringe tip. You now have two sterile tips exposed, and you need to take care not to contaminate either. Connect these two by screwing the Luer lock together. Now the sterile surfaces of this assembly are completely on the inside. You may now set this assembly down on the countertop if you need to, but do not at any time set either alone down on the countertop. Discard the wrappers in the non-sharp waste.

Preparing the compounded sterile product for intravenous infusion

Basic procedure for preparation of Compounded Sterile Products (CSPs)

Grasping the syringe by its barrel pull the cap of the needle straight off. This will expose the sterile needle. Place the needle cap on the alcohol pad on the work surface. You may wish to draw back on the plunger of the syringe to fill it with the amount of air, for which you would like to exchange with liquid injectable. For example, if you want 2 ml of a particular injectable in your IV, you may want to draw back your plunger to fill your syringe with 2 ml of air, push that air into the vial, and then withdraw your 2 ml of liquid. In this way, you have exchanged air for liquid in a way that does not over-pressurize the vial either positively or negatively. You will find this especially helpful when using large volumes of injectables, such as vitamin C.

On the other hand, when using very small volumes of an additive, keep in mind several factors: 1) the small volume of injectable in the needle shaft, 2) the curved or diagonal meniscus of fluids with a high surface tension (cohesive property of water and water soluble substances) or the adhesive property of fluids (the tendency to stick to the inner surface of the syringe, making an especially concave meniscus).

For each injectable that you use, hold the vial by its non-sterile glass surface in your non-dominant hand, and hold the syringe-needle assembly in your dominant hand. Inverting the glass vial over the needle, withdraw the amount of that particular nutrient that you have just determined, in consult and exam with your patient, how much you will need to add to his or her IV. Withdraw the plunger to the necessary volume as marked on the graduated syringe.

When you have drawn the injectable into the syringe, take it immediately to the designated CSP container, and plunge the liquid into the CSP by its insertion port or stopper, taking care not to touch or graze the sides of either the small vial or large container. You will need to keep the bevel of the needle inside the liquid in the vial, roughly at the shoulder of the vial. As the vial empties, that will become more difficult and will require your close attention, drawing the needle outward as the vial empties, in order to catch the last of the liquid.

You will then add the injectable to the CSP. Push out air from your syringe, until you see your injectable fluid arrive to the hub of the needle.

If the CSP is in a glass bottle, the injectable will be added downward into the bottle. One should aim for the exact center of the stopper. This is sometimes made easier if the approach of the needle is at a low angle, about 30 degrees, then straightened on contact, rather than a direct stab downward, which is harder to aim precisely. If the CSP is a plastic bag, the injectable will be added to the bag as it lays flat on the counter. Be very careful that your needle does not pierce the side of the bag’s injection port. Both require continuous attention, again, that all sterile surfaces are isolated from all non-sterile surfaces. Fingers should be nowhere near the insertion port on either the vial of the injectable or the glass bottle or the plastic bag. Fingers should also be nowhere near the Luer lock connection of the needle to the syringe, even while wearing gloves.

If there is resistance felt from positive pressure in an IV bag or especially a glass CSP, then allow some air to come back into your syringe after injecting. Try not to have much positive or negative pressure, because an excess either way can make it harder for the IV to be started and maintained at the desired drip rate later during infusion through the IV tubing. One could aim to draw out a volume of air roughly equivalent to the volume of fluid injected. That air can then be released into the room.

When you are finished with your syringe, you will want to recap it. We do not need to use a one-handed recap, because we have not touched any blood products in this process or other human specimen. Hold the syringe-needle assembly in the dominant hand, and the cap in the non-dominant hand, brace your two wrists together for stability, and carefully reinsert the needle straight into the cap, taking care to avoid a needle stick. Now you may unscrew the capped needle from the syringe. The needle goes in sharps, even if it is capped, because caps may possibly come loose later after being discarded. The syringe can go in non-sharp waste. Periodically throughout the addition of multiple additives to the CSP, the CSP is observed for any precipitates or exogenous particulate matter that may have been introduced.

Considerations regarding USP 797

The US Pharmacopeia produced the document entitled “USP 797: Pharmaceutical Compounding – Sterile Preparations” in 2003, then updated in 2008 and most recently in 2012. This document is widely considered to be influential regarding the handling of sterile compounded products for use in humans. It has obtained renewed relevance, because the FDA has indicated an interest in referring to USP 797 for guidelines on compounding sterile products. Yet strangely, this document is not readily available anywhere, nor is it linked on the FDA’s website, www.fda.gov. It is deeply hidden on the US Pharmacopeia, www.usp.org.

Yet, the complete document is not found there either from a search. It is at this address, and on websites in Texas, in China and from private parties. https://www.snmmi.org/files/docs/USP%20797.pdf

At the above link, the relevant text is different in respects that concern us from the link below. The above text is dated 2011 and 2012. The text below has no author or date: http://www.pharmacopeia.cn/v29240/usp29nf24s0_c797_viewall.html

What is found from a search of www.usp.org is the announcement that this document is currently being revised, as of December 2013, with no currently expected completion date.

The FDA has recently said that USP 797’s criteria for “low risk conditions” for CSP preparation are inherently safe.

Therefore, we examine below the categories of risk proposed in USP 797, and contrast those with the particular criteria for definition of risk suitable for the naturopathic profession and our patients.

First to put USP 797 in perspective, the introduction to the criteria for the various risk levels begins as follows:

“The characteristics described below for low-, medium-, and high-risk level CSPs are intended as a guide to the breadth and depth of care necessary in compounding, but they are neither exhaustive nor prescriptive. The licensed healthcare professionals who supervise compounding are responsible for determining the procedural and environmental quality practices and attributes that are necessary for the risk level they assign to specific CSPs.” (our emphasis.)

Nowhere in the USP 797 or anywhere in the extant FDA literature is there a command to only produce “low-risk level” compounded sterile products. The above paragraph makes clear that within the various risk levels, the healthcare professional uses medical judgment to ensure a safe product for the patient.

In fact the USP 797 lists, for each level of risk, established routine pharmaceutical industry procedures. The following are taken from the 2012 version of USP 797 at this link:

https://www.snmmi.org/files/docs/USP%20797.pdf

Low-risk level compounded sterile products

The USP 797 lists the following criteria for low-risk CSP preparation:

  1. CSPs are compounded in a laminar flow hood of ISO Class 5 or better air quality, using only sterile ingredients, products, components and devices.
  2. Compounding draws from three or fewer commercially manufactured packages of sterile products, and involves two or fewer entries into any one sterile container or package, or administration container or device. (Only in 2012 version).
  3. All handling of devices is done with aseptic technique.
  4. Before administration, the compounded sterile products are properly stored and not exposed for more than:
    1. 48 hours at controlled room temperature, or
    2. 14 days at a cold temperature, or
    3. 45 days in a solid frozen state

Medium-risk level compounded sterile products

The USP 797 lists the following criteria for medium-risk CSP preparation:

  1. Multiple doses of sterile product are combined to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions.
  2. The compounding process includes complex aseptic manipulations other than the single-volume transfer.
  3. The compounding process requires unusually long duration.
  4. Before administration, the compounded sterile products are properly stored and not exposed for more than:
    1. 30 hours at controlled room temperature, or
    2. 9 days at a cold temperature, or
    3. 45 days in a solid frozen state

High-risk level compounded sterile products

  1. Non-sterile ingredients are included, or a non-sterile device is employed before final sterilization.
  2. Any of the following are exposed to air quality worse than ISO Class 5 for more than 1 hour:
    1. Sterile contents of commercially manufactured products
    2. CSPs that lack effective antimicrobial preservatives,
    3. And sterile surfaces of devices and containers for the preparation, transfer, sterilization and packaging of CSPs.
  3. Compounding personnel are not wearing clean room garb and gloves.
  4. Non-sterile water containing preparations are stored for more than 6 hours before being sterilized.
  5. It is assumed, and not verified by examination of labelling and documentation from suppliers, or by direct determination, that the chemical purity and content and strength of ingredients meet their original specifications in open or unopened packaging.
  6. Before administration, the compounded sterile products are properly stored and not exposed for more than:
    1. 24 hours at controlled room temperature, or
    2. 3 days at a cold temperature, or
    3. 45 days in a solid frozen state

How these guidelines may be modified for naturopathic compounding

Low and high risk factors in naturopathic compounding

Storage

The compounded sterile product prepared by naturopathic physicians is of by far greatest value when administered to the patient immediately after preparation. Because oxidative chemical reactions within the CSP among its various constituents changes the value of the product for the patient to a great extent, the CSP is never stored for more than one hour before administration. In the clinic, if a patient has not started infusion within an hour of preparing the CSP, it is discarded, and a new one is made.

Air purity

The air quality in the IV preparation room is indoor air quality with air filters changed at least every two months.

Aseptic technique

Aseptic technique, as described in detail earlier in this manual, is strictly followed in order to ensure that sterile surfaces and products only come into contact with other sterile surfaces and products.

Dosing

A strict naturopathic standard is that the compounded sterile product is prepared for the individual, with the physician’s consideration not only of that person’s unique health circumstances, but with consideration of any acute circumstances on that particular day, at the time of consult, which is immediately prior to the CSP preparation. Therefore, it is never the case that one CSP is prepared for use with multiple patients.

Multiple component intravenous treatments

A basic cornerstone of naturopathic medicine is nutrition. And naturopathic physicians have been much more likely than other healthcare professionals to provide nutrition, whether diet, oral supplementation and/or intravenous nutrients to our patients.

Because of the intricate interconnectedness of the many biochemical pathways in the body, the interdependence of each of the nutrients on the presence of the others, and the established safety of multiple nutrients taken simultaneously (as established in the high degree of safety of a well-balanced meal), it is desirable and even necessary to use many different nutrients simultaneously when preparing the optimal naturopathic nutrition plan for the patient, whether dietary, otherwise oral, or intravenous nutrients. Therefore, it is not only acceptable, but desirable to dose many nutrients simultaneously.

Special considerations for the naturopathic clinic

Nutrition as a synergistic system

Multiple additive products in one CSP are not at all unheard of in allopathic pharmacy; yet naturopathic physicians are much more likely to use multiple additives due to the reasons below.

In naturopathic medicine the principles, the nature of the clinic and the modalities are very different than in conventional medicine. Nutrition generally plays a far more essential role than in allopathic pharmacy, and the USP 797 was written by and for the latter. Naturopathic physicians examine the role of diet, macronutrients and micronutrients, including in intravenous form, and we use all of these in our treatment protocols. Our understanding of biochemistry, specifically the metabolic pathways of the various nutrients, in complex interdependent relationships, requires that many nutrients be used, rather than few, for a most effective therapeutic approach to many health concerns and disease states. We inherited the bodies of our distant ancestors, people who had no access to contemporary pharmaceuticals, people who withstood extremes of temperature, exertion and vulnerability without our modern comforts, who relied only on the nutrients in the plants and animals they consumed. Going forward through millennia to the present, human nutritional needs have not changed much, and the multitude of nutrients used by our forebears is to our benefit as well.

For this reason, when we prepare intravenous nutrients for patients, it is far preferable to use more rather than fewer of these, so that the synergy of the whole is available to the patient.

Synergy of multiple injectables in one treatment

Metabolic pathways are routes of processing that occur in the body, primarily in the liver, and the substances that flow in these pathways are the nutrients, simply because they find and interact with other nutrients in an incredibly complex symphony, which comprises the programming or blueprint of good health. An excess of one or a few nutrients without other complementary ones is not a helpful situation for a healthy or a sick person. For either, the body then floods here but has a drought there, creating metabolic imbalance. Clinically then, we have had the most beneficial effect by giving multiple nutrients simultaneously in both oral and intravenous therapies.

The late Dr. John Myers MD of Baltimore developed and administered the combination of intravenous nutrients, later named the “Myers Cocktail” by Alan Gaby MD, who did much to further its widespread use after Dr. Myers’ death in 1984.

Since then, endless variations of the original combination of nutrients have been studied, developed and administered, primarily by naturopathic physicians. It is estimated that at least hundreds of thousands if not millions of these treatments have been administered worldwide, with patients flying to countries where they are available, in search of such treatment. Historically and culturally, naturopathic physicians and alternative MDs have given IV nutrients for decades, finding such treatment to be extremely low-risk when aseptic technique is used.

Maintaining sterility with multiple injectables

Whether a compounded sterile product has multiple or few nutrients, aseptic technique must be maintained throughout the procedures detailed in Section II under “Basic procedures for preparing a compounded sterile product.” We recognize that there is no inherent risk to sterility in continuing an aseptic procedure with multiple sterile substances. The suggestion in USP 797 that n + c sterile substances used implies greater risk than n sterile substances used, where n < 2, and represents a number of substances, and c is an arbitrary constant, does not have either a logical or empirical basis, and is therefore a faulty and unproven assumption.

Naturopathic standards of risk in IV treatment

Low-risk preparation of the naturopathic compounded sterile product
  1. Compounded sterile products are prepared only by the physician who has seen the patient immediately preceding this process. Only that healthcare professional is most familiar with the patient’s therapeutic needs, and best qualified to dose nutritional products or other medication to the patient.
  2. Aseptic technique is used throughout the preparation of the compounded sterile product, keeping in mind that sterile surfaces only touch sterile surfaces, and non-sterile surfaces only touch non-sterile, or briefly, disinfected surfaces as described above in Section II. ISO Class 5 air, such as in a laminar flow hood, is not necessary for low-risk IV production in a naturopathic clinic’s IV preparation room, as long as the above guidelines for hygiene and aseptic technique are adhered to by all personnel.
  3. Storage of naturopathic CSPs is not to exceed one hour under any circumstances; CSPs that have been prepared more than one hour before infusion into the patient are discarded, and a new one is prepared.
  4. CSPs contain multiple nutrients, rather than few, in order to best complement the body’s metabolic pathways. Calcium and magnesium are best given together, for example. The B vitamins function best when used together, etc.
High-risk preparation of the naturopathic compounded sterile product
  1. Clinic personnel, such as a medical assistant or pharmacist, prepare the compounded sterile products. Such persons may be very well trained in aseptic techniques, but are at risk for being a part of any possible miscommunication from the physician regarding the patient’s needs, particularly with regard to dosing.
  2. It is high risk to use any less than aseptic technique, as described above in Section II, in handling the substances and materials used in CSP preparation. This is not at all recommended, under any circumstances.
  3. Storage of CSPs exceeding one hour is not at all recommended, under any circumstances.
  4. CSPs are considered to be high-risk when there are few nutrients; such a disruption and uneven irrigation of the metabolic pathways is considered to be risky, and is strongly discouraged.

Individualized treatment

A cornerstone principle of naturopathic medicine is: Treat the Whole Person. Beginning with the recognition that all of the body, mind, emotions and spirit comprise an individual (i.e. not able to be divided) system or person, we understand the system-wide effects of any intervention that we take with the patient. Each person has a unique genetic and physiological make-up, as well as a unique medical history, and for our sicker patients, unique complexes of co-morbidities.

It is therefore our most responsible therapeutic role to honor, acknowledge and respond with the utmost agility to the patient’s unique therapeutic needs. Therefore, a treatment for one person will not be exactly what the next person needs. Likewise, our compounded sterile products are composed for the individual, not as if on an assembly line. For this reason, it is safest, and in each patient’s best interest for the physician to prepare the compounded sterile product, immediately after consultation.

Immune support

Compounded sterile products are very different from each other if composed of pharmaceuticals or of nutrients. In the first case, there is targeted, specific blockage or diversion of a metabolic pathway. In the second, there is the encouragement or irrigation, so to speak, of most or all of the metabolic needs of the patient.

Therefore in the first case, the immune system is not necessarily strengthened, whereas in the second, all of the bodily systems are supported and strengthened, including the immune system. It therefore seems prudent that USP 797’s guidance on compounding of sterile pharmaceutical products would take extra pains to ensure a completely sterile environment, rather than simply the hygienic and disinfected environment in which the naturopathic physician works.

For this reason, we do not recommend that the naturopathic physician work exclusively in a laminar flow cabinet wearing clean room garb, but we do not discourage it either. As USP 797 makes clear, “The licensed healthcare professionals who supervise compounding are responsible for determining the procedural and environmental quality practices and attributes that are necessary for the risk level they assign to specific CSPs.”

Post-production testing

We propose that testing for microbial and pyrogen contamination after a CSP is produced is more useful than undergoing extraordinary measures during production for the following reasons:

  1. Post-production testing is more important for the assurance to the patient that their IV solution is free of contaminants and pathogens.
  2. Such testing is more valuable to the health care practitioner as verifiable fact that their CSP was produced without contamination.
  3. And such testing is more reliable, providing tangible, recorded data, rather than having undergone meticulous extraordinary efforts in production, with only the hope that there was no “fly in the ointment” so to speak.

Plating and Incubation

Practically, a testing site should involve a laminar flow hood of ISO Class 5 specifications. Personnel doing such testing will wear appropriate clean room garb, such as hair cover, mask, goggles, foot covering and gown with fitted cuffs, and sterile gloves to cover the cuffs.

That person will receive a 2 ml sample from the fluid of a prepared CSP from the physician who has prepared it. The 2.0 ml sample will be delivered in a sterile syringe with a sterile cap. This sample will be double-bagged in plastic, labelled with the name of the source clinic, identifying patient data and the date. Testing is then done within one hour of delivery to the testing personnel, or refrigerated in a dedicated refrigerator no longer than 24 hours prior to testing.

A medical assistant or laboratory technician will accept the sample and plate it on blood agar plates, then place in a CO2 incubator for 72 hours, and then observe growth.

Naturopathic clinics that have such facilities may act as testing facilities for other naturopathic clinics and doctors, maintaining meticulous records of growth or no growth for each, with a record of date and place that the CSP was produced. A modest fee for such service may be charged.

In the event of growth of colonies

Any observed growth or lack of observable growth will be recorded in a log for that particular doctor or for that particular clinic. A copy of the log will be maintained at the testing site, in possession of the clinic, if permitted by the client clinic. And the original report will be provided to the doctor or clinic that produced the CSP. Confidential testing with anonymous identifiers may also be available. This may be desirable for clinics just beginning to establish procedures.

Laboratory identification of microbes

The testing clinic will examine the cultures microscopically to identify the microbe. If necessary, outside microbiology labs may be consulted.

In the event of evidence of pathogenic contamination, the laboratory technician will notify the doctor by telephone at the earliest opportunity, as soon as growth is observed. That doctor will be asked to bring in samples from a new CSP for testing, as well as his or her opened vials for additional testing, as the microbial contamination may have occurred from the exposed surfaces of stoppers on the source vials, due to handling of those vials after they were opened.

Examination of the patient who received the tainted product

The entire SOAP note of the patient who received the tainted product is recorded and placed next to the log where the microbial growth was recorded. That SOAP note will be geared to the following:

Subjective

The patient is asked to describe any symptoms he or she may have felt before, during or after the IV administration of the IV product that produced growth.

Objective

The patient will have their vital measurements taken, including temperature, with a record of what kind of thermometer was used, (temporal, auricular, oral). Blood is then drawn for a CBC and CMP, and sent to a lab.

Assessment

The physician then determines if there has been any material impact, either favorable or unfavorable, on the patient due to the administration of the compounded sterile product.

Plan

If necessary, a plan is prepared to best address any infection that the patient may have suffered, but only if warranted in the doctor’s best medical judgment.

Follow-up

The patient is examined at one week and two weeks after the CSP that produced the microbial growth, and evaluated for any signs or symptoms.

Appendix A

Testing Log Book

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Naturopathic physicians define the parameters of safety for the naturopathic profession

The naturopathic profession in North America is quite new, but has very old roots, in previous millennia, when humans only had nature in its unprocessed form for both food and medicine. The various means that earlier humans had available to them to address their own ailments and diseases come to the naturopathic profession, and are received eclectically, as we appreciate the vastness of nature’s medicines and search through it all for the best remedies for the peculiar needs of the patient in front of us.

As a very old profession then, we have more resources than any other medical profession. Yet politically, throughout North America, we are still small and new, and not yet strong enough to have asserted ourselves, or to have broadcast our principles and our priorities.

Naturopathic physicians have thus defaulted to the parameters and criteria established by other professions in moments and areas of our inattention or indecision or fear. It is therefore incumbent on us to fill in these gaps with our criteria and our priorities, established by the very high standards of our profession.

As USP 797 makes clear, it is the best judgment of the physician to decide what is in the best interests of his or her patient. Toward that end, we offer this manual of preparation of compounded sterile products for our naturopathic profession, with the ultimate goal of upholding our patients’ best interests and wellbeing.

Colleen Huber, NMD